Recall Z-1333-2016— Karl Storz Endovision, Inc.
Class II · Terminated
Class II FDA medical device recall by Karl Storz Endovision, Inc., initiated 2016-02-29, terminated 2016-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL. Reason: Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel..
- Recalling firm
- Karl Storz Endovision, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-29
- Terminated
- 2016-09-28
- Firm location
- Charlton, MA, United States
Product description
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
Reason for recall
Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel.
Data sourced from openFDA. This site is unofficial and independent of the FDA.